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ぜんそく高強度 vs Ics/Laba hs およびチオトロピウムで 3 倍 (TRIGGER) (TRIGGER)

2026年6月2日 更新者：Chiesi Farmaceutici S.p.A.

CHF 5993 200/6/12.5 µg pMDI を比較する 52 週間、無作為化、二重盲検、多国籍、多施設、能動制御、3 群並列群試験/6 µg pMDI (EXTRAFINE ジプロピオン酸ベクロメタゾンとホルモテロール フマル酸塩の固定配合剤) 単独またはオープンラベルのチオトロピウム 2.5 µg レスピマット® の上に加えて、長時間作用型 β2 アゴニストと組み合わせた高用量の吸入コルチコステロイドでコントロールされていない喘息患者

この研究の目的は、CHF 5993 200/6/12.5 の優位性を評価することです。 µg pMDI (極細ジプロピオン酸ベクロメタゾン + フマル酸ホルモテロール + 臭化グリコピロニウムの固定組み合わせ) 対 CHF 1535 200/6 µg pMDI (極細ジプロピオン酸ベクロメタゾン + フマル酸ホルモテロールの固定組み合わせ) CHF 5993 200/6/12.5 の効果を比較する µg pMDI 対 CHF 5993 200/6/12.5 肺機能パラメーターと増悪率に関して、またその安全性といくつかの健康経済の結果を評価するために、µg と非盲検のチオトロピウム 2.5µg を併用しました。

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This was a phase III, multicentre, randomised, double-blind study, with an open-label arm, active-controlled, 3-arm parallel group study to demonstrate both the superiority of CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg in terms of change from baseline in pre-dose FEV1 at Week 26 and a reduction of moderate and severe asthma exacerbation rate with CHF 5993 pMDI 200/6/12.5 μg compared to CHF 1535 pMDI 200/6 μg during the entire 52-week treatment period.

The study was performed in patients with uncontrolled asthma on high doses of inhaled corticosteroids (ICS) in combination with long acting β2-agonists LABAs). The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and all other requirements of local laws.

Patients completed the electronic diary (eDiary)/electronic peak flow meter (ePeakflowmeter) twice daily at home from screening to Week 52, recording asthma symptoms, treatment compliance, rescue intake and peak expiratory flow (PEF). The Asthma Control Questionnaire© (ACQ)-7 was completed at all visits from screening to Week 52. The EuroQuality of Life-5-Dimensional-3-Level (EQ-5D-3L™) questionnaire was completed at all visits from randomisation to Week 52. Health economic information was collected during the study. An independent Data Safety Monitoring Board was established for evaluation of the study and impartial safety assurance for patients. An Adjudication Committee was established to evaluate Major Adverse Cardiovascular Events.

Primary objective of the study were:

  • To demonstrate the superiority of CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg in terms of change from baseline in pre-dose forced expiratory volume in the 1st second (FEV1) at Week 26;
  • To demonstrate the reduction of moderate and severe asthma exacerbations rate with CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg during the entire 52-week treatment period.

The secondary endpoints included pooled analyse of 2 pivotal studies; this study (TRIGGER) and study (TRIMARAN). These 2 studies have similar study designs and study population.

CHF 1535 pMDI: fixed-dose combination (FDC) of BDP + FF + GB Dose: BDP 200 μg, FF 6 μg, GB 12.5 μg per actuation, 2 inhalations, BID. Total daily dose: BDP 800 μg, FF 24 μg, GB 50 μg.

BDP: Beclometasone dipropionate FF: Formoterol fumarate GB: Glycopyrronium bromide

研究の種類

介入

入学 (実際)

1437

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アルゼンチン
      • Buenos Aires、アルゼンチン
        • Chiesi Clinical Trial Site 432702
      • CABA、アルゼンチン
        • Chiesi Clinical Trial Site 432704
      • Mar del Plata、アルゼンチン
        • Chiesi Clinical Trial Site 432705
      • Quilmes、アルゼンチン
        • Chiesi Clinical Trial Site 432701
      • San Miguel de Tucumán、アルゼンチン
        • Chiesi Clinical Trial Site 432703
      • San Miguel de Tucumán、アルゼンチン
        • Chiesi Clinical Trial Site 432706
  • イギリス
      • Llanelli、イギリス
        • Chiesi Clinical Trial Site 826702
      • London、イギリス
        • Chiesi Clinical Trial Site 826703
      • Manchester、イギリス
        • Chiesi Clinical Trial Site 826704
      • Soham、イギリス
        • Chiesi Clinical Trial Site 826701
  • イタリア
      • Bologna、イタリア
        • Chiesi Clinical Trial Site 380704
      • Catania、イタリア
        • Chiesi Clinical Trial Site 380703
      • Genova、イタリア
        • Chiesi Clinical Trial Site 380701
      • Palermo、イタリア
        • Chiesi Clinical Trial Site 380705
      • Pavia、イタリア
        • Chiesi Clinical Trial Site 380702
      • Tradate、イタリア
        • Chiesi Clinical Trial Site 380706
  • ウクライナ
      • Dnipro、ウクライナ
        • Chiesi Clinical Trial Site 804701
      • Ivano-Frankivsk、ウクライナ
        • Chiesi Clinical Trial Site 804711
      • Kharkiv、ウクライナ
        • Chiesi Clinical Trial Site 804709
      • Kherson、ウクライナ
        • Chiesi Clinical Trial Site 804710
      • Kiev、ウクライナ
        • Chiesi Clinical Trial Site 804713
      • Kyiv、ウクライナ
        • Chiesi Clinical Trial Site 804705
      • Lviv、ウクライナ
        • Chiesi Clinical Trial Site 804712
      • Sumy、ウクライナ
        • Chiesi Clinical Trial Site 804715
      • Vinnytsia、ウクライナ
        • Chiesi Clinical Trial Site 804703
      • Vinnytsia、ウクライナ
        • Chiesi Clinical Trial Site 804706
      • Vinnytsia、ウクライナ
        • Chiesi Clinical Trial Site 804707
      • Vinnytsia、ウクライナ
        • Chiesi Clinical Trial Site 804714
      • Zaporizhzhya、ウクライナ
        • Chiesi Clinical Trial Site 804704
      • Zhytomyr、ウクライナ
        • Chiesi Clinical Trial Site 804708
  • スペイン
      • A Coruña、スペイン
        • Chiesi Clinical Trial Site 724702
      • Badajoz、スペイン
        • Chiesi Clinical Trial Site 724703
      • Badalona、スペイン
        • Chiesi Clinical Trial Site 724706
      • Madrid、スペイン
        • Chiesi Clinical Trial Site 724701
      • Madrid、スペイン
        • Chiesi Clinical Trial Site 724704
      • Málaga、スペイン
        • Chiesi Clinical Trial Site 724705
      • Sabadell、スペイン
        • Chiesi Clinical Trial Site 724707
  • スロバキア
      • Bratislava、スロバキア
        • Chiesi Clinical Trial Site 703704
      • Bratislava、スロバキア
        • Chiesi Clinical Trial Site 703707
      • Ilava、スロバキア
        • Chiesi Clinical Trial Site 703702
      • Košice、スロバキア
        • Chiesi Clinical Trial Site 703705
      • Košice、スロバキア
        • Chiesi Clinical Trial Site 703706
      • Nové Zámky、スロバキア
        • Chiesi Clinical Trial Site 703701
      • Prievidza、スロバキア
        • Chiesi Clinical Trial Site 703709
      • Spišská Nová Ves、スロバキア
        • Chiesi Clinical Trial Site 703703
      • Štúrovo、スロバキア
        • Chiesi Clinical Trial Site 703708
  • チェコ
      • Blansko、チェコ
        • Chiesi Clinical Trial Site 203711
      • Brandýs nad Labem、チェコ
        • Chiesi Clinical Trial Site 203702
      • Brno、チェコ
        • Chiesi Clinical Trial Site 203708
      • Jindřichův Hradec、チェコ
        • Chiesi Clinical Trial Site 203707
      • Kralupy nad Vltavou、チェコ
        • Chiesi Clinical Trial Site 203705
      • Miroslav、チェコ
        • Chiesi Clinical Trial Site 203709
      • Opava、チェコ
        • Chiesi Clinical Trial Site 203704
      • Prague、チェコ
        • Chiesi Clinical Trial Site 203701
      • Prague、チェコ
        • Chiesi Clinical Trial Site 203703
      • Prague、チェコ
        • Chiesi Clinical Trial Site 203710
      • Rokycany、チェコ
        • Chiesi Clinical Trial Site 203713
      • Teplice、チェコ
        • Chiesi Clinical Trial Site 203706
      • Varnsdorf、チェコ
        • Chiesi Clinical Trial Site 203712
  • トルコ（Türkiye）
      • Ankara、トルコ（Türkiye）
        • Chiesi Clinical Trial Site 792701
      • Ankara、トルコ（Türkiye）
        • Chiesi Clinical Trial Site 792702
      • Antalya、トルコ（Türkiye）
        • Chiesi Clinical Trial Site 792703
      • Aydin、トルコ（Türkiye）
        • Chiesi Clinical Trial Site 792710
      • Istanbul、トルコ（Türkiye）
        • Chiesi Clinical Trial Site 792707
      • Kocaeli、トルコ（Türkiye）
        • Chiesi Clinical Trial Site 792706
      • Maltepe、トルコ（Türkiye）
        • Chiesi Clinical Trial Site 792705
      • Mersin、トルコ（Türkiye）
        • Chiesi Clinical Trial Site 792708
      • Yenişehir、トルコ（Türkiye）
        • Chiesi Clinical Trial Site 792709
  • ドイツ
      • Berlin、ドイツ
        • Chiesi Clinical Trial Site 276709
      • Berlin、ドイツ
        • Chiesi Clinical Trial Site 276712
      • Bonn、ドイツ
        • Chiesi Clinical Trial Site 276711
      • Frankfurt am Main、ドイツ
        • Chiesi Clinical Trial Site 276707
      • Frankfurt am Main、ドイツ
        • Chiesi Clinical Trial Site 276714
      • Hamburg、ドイツ
        • Chiesi Clinical Trial Site 276705
      • Hanover、ドイツ
        • Chiesi Clinical Trial Site 276703
      • Koblenz、ドイツ
        • Chiesi Clinical Trial Site 276708
      • Leipzig、ドイツ
        • Chiesi Clinical Trial Site 276702
      • Leipzig、ドイツ
        • Chiesi Clinical Trial Site 276704
      • Leipzig、ドイツ
        • Chiesi Clinical Trial Site 276710
      • Mainz、ドイツ
        • Chiesi Clinical Trial Site 276715
      • München、ドイツ
        • Chiesi Clinical Trial Site 276701
      • Münster、ドイツ
        • Chiesi Clinical Trial Site 276713
      • Rosenheim、ドイツ
        • Chiesi Clinical Trial Site 276716
  • ハンガリー
      • Balassagyarmat、ハンガリー
        • Chiesi Clinical Trial Site 348707
      • Budapest、ハンガリー
        • Chiesi Clinical Trial Site 348715
      • Debrecen、ハンガリー
        • Chiesi Clinical Trial Site 348721
      • Gödöllő、ハンガリー
        • Chiesi Clinical Trial Site 348712
      • Hatvan、ハンガリー
        • Chiesi Clinical Trial Site 348718
      • Komárom、ハンガリー
        • Chiesi Clinical Trial Site 348717
      • Létavértes、ハンガリー
        • Chiesi Clinical Trial Site 348709
      • Monor、ハンガリー
        • Chiesi Clinical Trial Site 348703
      • Mórahalom、ハンガリー
        • Chiesi Clinical Trial Site 348719
      • Nyíregyháza、ハンガリー
        • Chiesi Clinical Trial Site 348704
      • Nyíregyháza、ハンガリー
        • Chiesi Clinical Trial Site 348714
      • Pécs、ハンガリー
        • Chiesi Clinical Trial Site 348713
      • Pécs、ハンガリー
        • Chiesi Clinical Trial Site 348720
      • Siófok、ハンガリー
        • Chiesi Clinical Trial Site 348702
      • Szarvas、ハンガリー
        • Chiesi Clinical Trial Site 348706
      • Szeged、ハンガリー
        • Chiesi Clinical Trial Site 348701
      • Szombathely、ハンガリー
        • Chiesi Clinical Trial Site 348705
      • Vásárosnamény、ハンガリー
        • Chiesi Clinical Trial Site 348710
      • Érd、ハンガリー
        • Chiesi Clinical Trial Site 348708
  • ブルガリア
      • Blagoevgrad、ブルガリア
        • Chiesi Clinical Trial Site 100707
      • Burgas、ブルガリア
        • Chiesi Clinical Trial Site 100720
      • Gabrovo、ブルガリア
        • Chiesi Clinical Trial Site 100718
      • Haskovo、ブルガリア
        • Chiesi Clinical Trial Site 100713
      • Montana、ブルガリア
        • Chiesi Clinical Trial Site 100722
      • Pleven、ブルガリア
        • Chiesi Clinical Trial Site 100702
      • Plovdiv、ブルガリア
        • Chiesi Clinical Trial Site 100705
      • Plovdiv、ブルガリア
        • Chiesi Clinical Trial Site 100708
      • Plovdiv、ブルガリア
        • Chiesi Clinical Trial Site 100715
      • Rousse、ブルガリア
        • Chiesi Clinical Trial Site 100716
      • Sofia、ブルガリア
        • Chiesi Clinical Trial Site 100701
      • Sofia、ブルガリア
        • Chiesi Clinical Trial Site 100703
      • Sofia、ブルガリア
        • Chiesi Clinical Trial Site 100704
      • Sofia、ブルガリア
        • Chiesi Clinical Trial Site 100709
      • Sofia、ブルガリア
        • Chiesi Clinical Trial Site 100719
      • Stara Zagora、ブルガリア
        • Chiesi Clinical Trial Site 100706
      • Stara Zagora、ブルガリア
        • Chiesi Clinical Trial Site 100712
      • Varna、ブルガリア
        • Chiesi Clinical Trial Site 100710
      • Vidin、ブルガリア
        • Chiesi Clinical Trial Site 100711
      • Vidin、ブルガリア
        • Chiesi Clinical Trial Site 100721
  • ベラルーシ
      • Homyel、ベラルーシ
        • Chiesi Clinical Trial Site 112703
      • Homyel、ベラルーシ
        • Chiesi Clinical Trial Site 112704
      • Minsk、ベラルーシ
        • Chiesi Clinical Trial Site 112701
      • Minsk、ベラルーシ
        • Chiesi Clinical Trial Site 112702
      • Minsk、ベラルーシ
        • Chiesi Clinical Trial Site 112705
  • ポルトガル
      • Aveiro、ポルトガル
        • Chiesi Clinical Trial Site 620704
      • Figueira da Foz Municipality、ポルトガル
        • Chiesi Clinical Trial Site 620703
      • Lisbon、ポルトガル
        • Chiesi Clinical Trial Site 620702
      • Loures、ポルトガル
        • Chiesi Clinical Trial Site 620708
      • Vila Nova de Gaia、ポルトガル
        • Chiesi Clinical Trial Site 620707
  • ポーランド
      • Bialystok、ポーランド
        • Chiesi Clinical Trial Site 616713
      • Bialystok、ポーランド
        • Chiesi Clinical Trial Site 616718
      • Bielsko-Biala、ポーランド
        • Chiesi Clinical Trial Site 616722
      • Bienkówka、ポーランド
        • Chiesi Clinical Trial Site 616702
      • Bydgoszcz、ポーランド
        • Chiesi Clinical Trial Site 616727
      • Giżycko、ポーランド
        • Chiesi Clinical Trial Site 616704
      • Grudziądz、ポーランド
        • Chiesi Clinical Trial Site 616716
      • Katowice、ポーランド
        • Chiesi Clinical Trial Site 616725
      • Katowice、ポーランド
        • Chiesi Clinical Trial Site 616729
      • Krakow、ポーランド
        • Chiesi Clinical Trial Site 616719
      • Krakow、ポーランド
        • Chiesi Clinical Trial Site 616734
      • Krakow、ポーランド
        • Chiesi Clinical Trial Site 616736
      • Lodz、ポーランド
        • Chiesi Clinical Trial Site 616707
      • Lodz、ポーランド
        • Chiesi Clinical Trial Site 616708
      • Lodz、ポーランド
        • Chiesi Clinical Trial Site 616711
      • Lodz、ポーランド
        • Chiesi Clinical Trial Site 616726
      • Mrozy、ポーランド
        • Chiesi Clinical Trial Site 616733
      • Ostróda、ポーランド
        • Chiesi Clinical Trial Site 616717
      • Otwock、ポーランド
        • Chiesi Clinical Trial Site 616731
      • Pabianice、ポーランド
        • Chiesi Clinical Trial Site 616703
      • Poznan、ポーランド
        • Chiesi Clinical Trial Site 616709
      • Poznan、ポーランド
        • Chiesi Clinical Trial Site 616728
      • Proszowice、ポーランド
        • Chiesi Clinical Trial Site 616720
      • Rzeszów、ポーランド
        • Chiesi Clinical Trial Site 616723
      • Rzeszów、ポーランド
        • Chiesi Clinical Trial Site 616735
      • Skierniewice、ポーランド
        • Chiesi Clinical Trial Site 616721
      • Strzelce Opolskie、ポーランド
        • Chiesi Clinical Trial Site 616732
      • Tarnów、ポーランド
        • Chiesi Clinical Trial Site 616710
      • Warsaw、ポーランド
        • Chiesi Clinical Trial Site 616701
      • Wilkowice、ポーランド
        • Chiesi Clinical Trial Site 616730
      • Wroclaw、ポーランド
        • Chiesi Clinical Trial Site 616705
      • Wroclaw、ポーランド
        • Chiesi Clinical Trial Site 616714
      • Wroclaw、ポーランド
        • Chiesi Clinical Trial Site 616715
      • Świdnik、ポーランド
        • Chiesi Clinical Trial Site 616712
  • リトアニア
      • Vilnius、リトアニア
        • Chiesi Clinical Trial Site 440702
      • Vilnius、リトアニア
        • Chiesi Clinical Trial Site 440703
      • Vilnius、リトアニア
        • Chiesi Clinical Trial Site 440705
      • Šiauliai、リトアニア
        • Chiesi Clinical Trial Site 440701
  • ルーマニア
      • Alexandru cel Bun、ルーマニア
        • Chiesi Clinical Trial Site 642715
      • Arad、ルーマニア
        • Chiesi Clinical Trial Site 642713
      • Bacau、ルーマニア
        • Chiesi Clinical Trial Site 642722
      • Bragadiru、ルーマニア
        • Chiesi Clinical Trial Site 642717
      • Brasov、ルーマニア
        • Chiesi Clinical Trial Site 642706
      • Bucharest、ルーマニア
        • Chiesi Clinical Trial Site 642703
      • Bucharest、ルーマニア
        • Chiesi Clinical Trial Site 642707
      • Bucharest、ルーマニア
        • Chiesi Clinical Trial Site 642708
      • Bucharest、ルーマニア
        • Chiesi Clinical Trial Site 642719
      • Bucharest、ルーマニア
        • Chiesi Clinical Trial Site 642723
      • Cluj-Napoca、ルーマニア
        • Chiesi Clinical Trial Site 642709
      • Cluj-Napoca、ルーマニア
        • Chiesi Clinical Trial Site 642714
      • Cluj-Napoca、ルーマニア
        • Chiesi Clinical Trial Site 642716
      • Cluj-Napoca、ルーマニア
        • Chiesi Clinical Trial Site 642718
      • Cluj-Napoca、ルーマニア
        • Chiesi Clinical Trial Site 642726
      • Craiova、ルーマニア
        • Chiesi Clinical Trial Site 642712
      • Iași、ルーマニア
        • Chiesi Clinical Trial Site 642704
      • Iași、ルーマニア
        • Chiesi Clinical Trial Site 642710
      • Oradea、ルーマニア
        • Chiesi Clinical Trial Site 642705
      • Suceava、ルーマニア
        • Chiesi Clinical Trial Site 642711
      • Timișoara、ルーマニア
        • Chiesi Clinical Trial Site 642721
  • ロシア
      • Chelyabinsk、ロシア
        • Chiesi Clinical Trial Site 643727
      • Chelyabinsk、ロシア
        • Chiesi Clinical Trial Site 643733
      • Chelyabinsk、ロシア
        • Chiesi Clinical Trial Site 643745
      • Izhevsk、ロシア
        • Chiesi Clinical Trial Site 643754
      • Kazan'、ロシア
        • Chiesi Clinical Trial Site 643713
      • Kazan'、ロシア
        • Chiesi Clinical Trial Site 643719
      • Kazan'、ロシア
        • Chiesi Clinical Trial Site 643741
      • Kazan'、ロシア
        • Chiesi Clinical Trial Site 643746
      • Kemerovo、ロシア
        • Chiesi Clinical Trial Site 643704
      • Kemerovo、ロシア
        • Chiesi Clinical Trial Site 643731
      • Moscow、ロシア
        • Chiesi Clinical Trial Site 643702
      • Moscow、ロシア
        • Chiesi Clinical Trial Site 643705
      • Moscow、ロシア
        • Chiesi Clinical Trial Site 643706
      • Moscow、ロシア
        • Chiesi Clinical Trial Site 643718
      • Moscow、ロシア
        • Chiesi Clinical Trial Site 643722
      • Moscow、ロシア
        • Chiesi Clinical Trial Site 643735
      • Moscow、ロシア
        • Chiesi Clinical Trial Site 643743
      • Nizhny Novgorod、ロシア
        • Chiesi Clinical Trial Site 643707
      • Nizhny Novgorod、ロシア
        • Chiesi Clinical Trial Site 643723
      • Nizhny Novgorod、ロシア
        • Chiesi Clinical Trial Site 643744
      • Novosibirsk、ロシア
        • Chiesi Clinical Trial Site 643717
      • Odintsovo、ロシア
        • Chiesi Clinical Trial Site 643724
      • Orenburg、ロシア
        • Chiesi Clinical Trial Site 643729
      • Pyatigorsk、ロシア
        • Chiesi Clinical Trial Site 643711
      • Ryazan、ロシア
        • Chiesi Clinical Trial Site 643701
      • Saint Petersburg、ロシア
        • Chiesi Clinical Trial Site 643712
      • Saint Petersburg、ロシア
        • Chiesi Clinical Trial Site 643714
      • Saint Petersburg、ロシア
        • Chiesi Clinical Trial Site 643715
      • Saint Petersburg、ロシア
        • Chiesi Clinical Trial Site 643716
      • Saint Petersburg、ロシア
        • Chiesi Clinical Trial Site 643725
      • Saint Petersburg、ロシア
        • Chiesi Clinical Trial Site 643730
      • Saint Petersburg、ロシア
        • Chiesi Clinical Trial Site 643732
      • Saint Petersburg、ロシア
        • Chiesi Clinical Trial Site 643737
      • Saint Petersburg、ロシア
        • Chiesi Clinical Trial Site 643739
      • Saint Petersburg、ロシア
        • Chiesi Clinical Trial Site 643752
      • Saint Petersburg、ロシア
        • Chiesi Clinical Trial Site 643757
      • Saint Petersburg、ロシア
        • Chiesi Clinical Trial Site 643758
      • Saratov、ロシア
        • Chiesi Clinical Trial Site 643703
      • Saratov、ロシア
        • Chiesi Clinical Trial Site 643736
      • Smolensk、ロシア
        • Chiesi Clinical Trial Site 643726
      • Stavropol、ロシア
        • Chiesi Clinical Trial Site 643740
      • Tomsk、ロシア
        • Chiesi Clinical Trial Site 643709
      • Tomsk、ロシア
        • Chiesi Clinical Trial Site 643728
      • Tomsk、ロシア
        • Chiesi Clinical Trial Site 643759
      • Ufa、ロシア
        • Chiesi Clinical Trial Site 643755
      • Vladikavkaz、ロシア
        • Chiesi Clinical Trial Site 643708
      • Vladimir、ロシア
        • Chiesi Clinical Trial Site 643738
      • Voronezh、ロシア
        • Chiesi Clinical Trial Site 643710
      • Yaroslavl、ロシア
        • Chiesi Clinical Trial Site 643720
      • Yaroslavl、ロシア
        • Chiesi Clinical Trial Site 643734
      • Yaroslavl、ロシア
        • Chiesi Clinical Trial Site 643742
      • Yaroslavl、ロシア
        • Chiesi Clinical Trial Site 643749
      • Yekaterinburg、ロシア
        • Chiesi Clinical Trial Site 643721

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  • -1年以上の喘息の病歴があり、40歳より前に診断された
  • -高用量の吸入コルチコステロイド（ICS）と長時間作用型ベータ2アゴニスト（LABA）の組み合わせによる二重療法のみの制御されていない喘息 ACQ-7（喘息コントロールアンケート）≥1.5
  • 気管支拡張薬投与前の FEV1 < 予測正常値の 80%
  • 陽性可逆性試験
  • 前年に喘息の増悪が少なくとも1回記録されている

除外基準:

  • 妊娠中または授乳中の女性
  • 慢性閉塞性肺疾患（COPD）の診断
  • -4週間前のスクリーニングで喘息の増悪または呼吸器感染症の患者
  • 現在の喫煙者または元喫煙者 (>= 年に 10 パック)
  • -4週間前のスクリーニングにおけるICS + LABAの組み合わせの用量、スケジュール、または製剤の変更

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：CHF 5993 200/6/12.5 µg

治療A:

5993 スイス フラン 200/6/12.5 µg: 2 回吸入入札 1 日総投与量: 800/24/50 µg BDP/FF/GB
薬：CHF 5993 200/6/12.5 µg
アクティブコンパレータ：CHF 1535 200/6 µg

治療 B:

CHF 1535 200/6 µg: 2 回吸入 1 日総投与量: 800/24 µg BDP/FF
薬：CHF 1535 200/6 µg
アクティブコンパレータ：CHF 1535 200/6 µg + チオトロピウム レスピマット 2.5 µg

治療 C (非盲検群):

CHF 1535 200/6 µg: 2 回吸入

+ チオトロピウム レスピマット 2.5 µg: 2 吸入 od 1 日総投与量: 800/24 µg BDP/FF + 5 µg Tio
薬：CHF 1535 200/6 µg + チオトロピウム レスピマット 2.5 µg

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26
時間枠：Week 0 (pre-treatment, baseline) to Week 26.

Change from baseline in pre-dose FEV1, analysed at Week 26 of treatment.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 26.
2_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period
時間枠：Week 0 (pre-treatment, baseline) to Week 52.

Asthma exacerbation intensity: Moderate AND Severe Asthma Exacerbation

Severe: asthma worsening requiring initiation of treatment with systemic corticosteroids for at least 3 days (courses of corticosteroids separated by ≥1 week treated as separate severe exacerbations).

Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:

  • Nocturnal awakening(s) due to asthma requiring SABA for 2 consecutive nights/increase of ≥ 0.75 from baseline in daily symptom score on 2 consecutive days; increase from baseline in occasions of SABA use on 2 consecutive days (minimum increase 4 puffs/day);
  • ≥20% decrease in peak expiratory flow from baseline on at least 2 consecutive mornings/evenings or ≥ 20% decrease in FEV1 from baseline;
  • Visit to the ER/trial site for asthma treatment not requiring systemic corticosteroid;
Week 0 (pre-treatment, baseline) to Week 52.

二次結果の測定

結果測定
メジャーの説明
時間枠
3_Change From Baseline in Peak(0-3h) FEV1 at Week 26
時間枠：Week 0 (pre-treatment, baseline) and Week 26.

Peak peak of forced expiratory volume in the first second (FEV1) within 3 hours post-dose.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) and Week 26.
4_Change From Baseline in Morning Peak Expiratory Flow (PEF) Over the 26-Week Treatment
時間枠：Week 0 (pre-treatment, baseline) to Week 26.

Change from baseline in the average morning PEF (Litre/min), measured by patients at home over the 26-week treatment period (i.e., up to Week 26).

PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 26.
5_Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period - Pooled Analysis
時間枠：The entire treatment period; up to Week 52.

Severe asthma exacerbation rate over the 52-Week treatment period in a pre-specified pooled analysis of 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
The entire treatment period; up to Week 52.
6_Change From Baseline in Peak FEV1 (0-3h) at All Clinical Visits
時間枠：Week 0 (pre-treatment, baseline) to Week 52.

The peak (0-3h) FEV1 at baseline and at all subsequent visits, and the respective changes from baseline are presented by treatment group for all clinical visits.

Baseline for pre-dose FEV1 was calculated as average of the FEV1 measurements (L) from the visit 2 (V2) Pre45min & V2 Pre15min. If one of the two pre-dose values was missing, the baseline was equal to the available pre-dose value.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 52.
7_Change From Baseline in Pre-Dose FEV1 at All Clinical Visits
時間枠：Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in pre-dose FEV1 at all clinical visits.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 52.
8_FEV1 Response (FEV1 ≥ 100 mL) at Week 26 and Week 52
時間枠：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Results show the percentage of patients classified as FEV1 responders at Week 26 and at Week 52.

The FEV1 response was defined as: Change from baseline in pre-dose morning FEV1 ≥ 100 mL.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
9_Change From Baseline in FEV1 Area Under the Curve (AUC) (0-3h) Normalised by Time at All Clinical Visits
時間枠：Week 0 (pre-treatment, baseline) to Week 52.

Baseline definition: mean of two pre-dose FEV1 measurements at visit 2 (V2).

Results show the change from baseline in FEV1 area under the curve [AUC] (0-3h) at all subsequent visits (i.e. change from baseline of the AUC of the serial post-dose spirometry assessments till 3h post-dose).

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 52.
10_Change From Baseline in the Asthma Control Questionnaire-7 (ACQ-7) Score at All Clinical Visits
時間枠：Week 0 (pre-treatment, baseline) to Week 52.

ACQ-7 Questionnaire.

ACQ-7 allows assessment of asthma control in individual patients.

The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on lung function (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control (no impairment) and 6 indicating poor control (maximum impairment). The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer.

Baseline for ACQ-7 was the total score recorded at Visit 2 (Week 0) of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. A negative change from baseline indicates improvement in lung function.
Week 0 (pre-treatment, baseline) to Week 52.
11_Asthma Control Questionnaire©-7 Response at Week 26 and Week 52
時間枠：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Asthma Control Questionnaire (ACQ) and Asthma Control Questionnaire-7 (QAC-7) are defined in the description of Outcome measure 10 above.

An ACQ-7 response was defined as change from baseline (Week 0, pre-dose) in ACQ-7 score ≤ -0.5; non-response was defined as change from baseline in ACQ-7 score >-0.5 or missing data.

Results represent responders (i.e. change from baseline in ACQ-7 Score ≤ -0.5) at Week 26 and at Week 52.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
12_Change From Baseline in Average Morning PEF (L/Min) Over 52 Weeks of Treatment
時間枠：Week 0 (pre-treatment, baseline) to Week 52.

Change from baseline in average MORNING PEF (L/min) over 52 weeks of treatment.

PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 52.
12a_Change From Baseline in Average Evening PEF (L/Min) Over 26 and 52 Weeks of Treatment
時間枠：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in average EVENING PEF (L/min) over 26 and 52 weeks of treatment.

PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
13_Number of Patients at Risk of Moderate or Severe Asthma Exacerbation Over 52 Weeks
時間枠：Week 0 (pre-treatment, baseline) to Week 52.

Number of patients at risk of a moderate or severe asthma exacerbation.

Results show the number of patients who had moderate or severe asthma exacerbation over the 52 weeks treatment period.
Week 0 (pre-treatment, baseline) to Week 52.
14_Number of Patients at Risk of Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
時間枠：Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Number of patients at risk of a SEVERE asthma exacerbation in the pooled analysis of the two pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER), over the 52 weeks treatment period.

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
15_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02.
時間枠：Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

MODERATE asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-055993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
16_Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
時間枠：Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02.

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
17_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02
時間枠：Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Moderate AND severe asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
18_Number of Patients at Risk of Moderate OR Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
時間枠：Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Time to first MODERATE OR SEVERE asthma exacerbation in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
19_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period
時間枠：Week 0 (pre-treatment, baseline) to Week 52.

MODERATE asthma exacerbation rate over the 52-Week treatment period.

Asthma exacerbation intensity: Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:

  • Nocturnal awakening(s) due to asthma requiring SABA for 2 consecutive nights/increase of ≥ 0.75 from baseline in daily symptom score on 2 consecutive days; increase from baseline in occasions of SABA use on 2 consecutive days (minimum increase 4 puffs/day);
  • ≥20% decrease in peak expiratory flow from baseline on at least 2 consecutive mornings/evenings or ≥ 20% decrease in FEV1 from baseline;
  • Visit to the ER/trial site for asthma treatment not requiring systemic corticosteroid;
Week 0 (pre-treatment, baseline) to Week 52.
20_Number of Patients at Risk of a MODERATE Asthma Exacerbation
時間枠：Week 0 (pre-treatment, baseline) to Week 52.
Data were analysed for the number of patients at risk of a MODERATE asthma exacerbation.
Week 0 (pre-treatment, baseline) to Week 52.
21_Change From Baseline in the Average Use of Rescue Medication Over the 26- and 52-Week Treatment Periods
時間枠：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in the average use of rescue medication over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
21a_Change From Baseline in the Average Use of Rescue Medication in Each Inter-Visit Period
時間枠：Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the average use (puffs/day) of rescue medication in each inter-visit period.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 52.
22_Change From Baseline in the Percentage of Rescue Medication-Free Days Over the 26- and 52-Week Treatment Periods
時間枠：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in the percentage of rescue medication-free days over the 26- and 52-Week treatment periods.

Data was collected using an electronic daily diary, from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
22a_Change From Baseline in the Percentage of Rescue Medication-Free Days in Each Inter-Visit Period Over the Treatment
時間枠：Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the percentage of rescue medication-free days in each inter-visit period over the entire treatment.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 52.
23_Change From Baseline in the Average Total Daily Asthma Symptom Scores Over the 26- and 52-Week Treatment Periods
時間枠：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Results show the change from baseline in the average total daily asthma symptom scores over the 26- and 52-Weeks of treatment. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered: cough, wheeze, chest tightness, breathlessness.

Morning (night-time asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Symptoms not causing awakening;
  • 2 Moderate = Discomfort enough to cause awakenings;
  • 3 Severe = Causing awakenings for most of the night/did not sleep at all.

Evening (daytime asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Aware of symptoms, which could be easily tolerated;
  • 2 Moderate = Discomfort enough to cause interference with daily activity;
  • 3 Severe = Incapacitating
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
23a_Change From Baseline in the Average Daily Asthma Symptom Scores in Each Inter-Visit Period
時間枠：Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the average total daily asthma symptom scores over the 26- and 52-Weeks of treatment. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered: cough, wheeze, chest tightness, breathlessness.

Morning (night-time asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Symptoms not causing awakening;
  • 2 Moderate = Discomfort enough to cause awakenings;
  • 3 Severe = Causing awakenings for most of the night/did not sleep at all.

Evening (daytime asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Aware of symptoms, which could be easily tolerated;
  • 2 Moderate = Discomfort enough to cause interference with daily activity;
  • 3 Severe = Incapacitating
Week 0 (pre-treatment, baseline) to Week 52.
24_Change From Baseline in the Percentage of Asthma Symptom-Free Days Over the 26- and 52-Week Treatment Periods
時間枠：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in the percentage of asthma symptom-free days over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.

Results show the change from baseline in the average daily asthma symptom scores over the 26- and 52-Week treatment periods. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness.

An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
24a_Change From Baseline in the Percentage of Asthma Symptom-Free Days in Each Inter-Visit Periods
時間枠：Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the percentage of asthma symptom-free days in each inter-visit periods over the entire treatment.

Data was collected through an electronic daily diary from screening to end of the study.

A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness.

An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23.
Week 0 (pre-treatment, baseline) to Week 52.
25_Change From Baseline in the Percentage of Asthma Control Days Over the 26- and 52-Week Treatment Periods
時間枠：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Results show the change from baseline in the percentage of asthma control days over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.

Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness):

Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all).

Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/take part in usual activity).
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
25a_Change From Baseline in the Percentage of Asthma Control Days in Each Inter-Visit Period
時間枠：Week 0 (pre-treatment, baseline) to Week 52.

A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Data was collected through an electronic daily diary from screening to the end of the study.

Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness):

Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all).

Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/ take part in usual activity).
Week 0 (pre-treatment, baseline) to Week 52.

その他の成果指標

結果測定
メジャーの説明
時間枠
有害事象と副作用
時間枠：52週目まで
52週目まで
医療経済学の成果の収集
時間枠：0週から52週
医療資源の総使用量と休業
0週から52週

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Chiesi Farmaceutici S.p.A.

捜査官

  • 主任研究者：Georgio Walter Canonica, MD、University of Medicine, Genoa, Italy

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2016年4月6日

一次修了 (実際)

2018年5月28日

研究の完了 (実際)

2018年5月28日

試験登録日

最初に提出

2016年2月3日

QC基準を満たした最初の提出物

2016年2月3日

最初の投稿 (推定)

2016年2月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月26日

QC基準を満たした最後の更新が送信されました

2026年6月2日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CCD-05993AB2-02
  • 2015-000717-40 (EudraCT番号)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Chiesi は、資格のある科学および医学研究者と共有し、正当な研究、患者レベルのデータ、研究レベルのデータ、臨床プロトコル、および完全な CSR を実施し、商業上の機密情報と患者を保護するという原則に一貫して臨床試験情報へのアクセスを提供することを約束します。プライバシー。 共有される患者レベルのデータは、個人を特定できる情報を保護するために匿名化されます。

Chiesi のアクセス基準と臨床データ共有の完全なプロセスは、Chiesi Group の Web サイトで入手できます。

IPD 共有時間枠

See information above in Plan Description regarding Chiesi's commitment to share information with qualified scientific and medical researchers, conducting legitimate research

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

IPD 共有アクセス基準

Chiesi のアクセス基準と臨床データ共有の完全なプロセスは、Chiesi Group の Web サイトで入手できます。

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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